6 Interactions found for:

The following applies to the ingredients: Empagliflozin (found in Jardiance)

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Use should be avoided, especially during the second and third trimesters of pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not Assigned

Risk Summary: There is limited data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage. Based on animal data, this drug may cause adverse renal effects in the developing fetus.

Comments:
-Poorly controlled diabetes in pregnancy increases the risk of adverse maternal and fetal outcomes.

Animal studies have revealed evidence of adverse renal changes and embryofetal toxicity. Administration of this drug to pregnant animals during the period of organogenesis at doses up to 154 times the maximum clinical dose based on AUC resulted in maternal/fetal toxicity, malformations, and reduced offspring body weights. In juvenile rats, direct exposure to this drug at doses approximately 13 times the maximum clinical dose caused increased kidney weights and renal tubular/pelvic dilatations. These findings occurred during a period of renal development in rats corresponding to the late second and third trimester of human renal development. Animal studies do not indicate direct or indirect harmful effects with respect to fertility. There are no controlled data in human pregnancy.

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Fetal risks of poorly controlled diabetes in pregnancy include an increased risk for major birth defects, stillbirth, and macrosomia-related morbidity.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Metformin

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Benefit should outweigh risk

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Data are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; published studies have not reported an increased risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Maternal glucose levels should be well controlled prior to conception and throughout pregnancy to avoid maternal and fetal diabetes-associated risks.
-Premenopausal women should understand the potential for unintended pregnancy with use of this drug as ovulation may occur in some anovulatory women.

Animal studies do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled maternal diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Published evidence suggests this drug has a good safety profile in women with no increased long-term effects in offspring up to 18 months; however, much of the evidence is from observational, small, and/or nonrandomized studies, and therefore data must be interpreted cautiously.

Many experts continue to recommend insulin as the drug of choice for type 1, type 2, and gestational diabetes when diet alone is unsuccessful in controlling blood sugars. The estimated background risk for major birth defects in women with pre-gestational diabetes mellitus with an HbA1C greater than 7 is 6% to 10% and for women with a HbA1C greater than 10, this risk has been reported to be as high as 20% to 25%. In the US, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated risk of miscarriage for pregnant women with diabetes is unknown. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Empagliflozin (found in Jardiance)

Professional Content

Use is not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-A risk to the breastfed infant cannot be excluded; there is a potential for serious adverse effects on postnatal renal development.
-An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug accumulation was observed in the milk of lactating animals. Studies in juvenile rats with direct exposure demonstrated pelvic and tubular dilations of the kidney during maturation. Human kidney maturation occurs in utero and during the first 2 years of life; thus, a potential for serious harm to the developing kidney may exist for infants exposed to this drug during breastfeeding. However, some experts anticipate low amounts of this drug in human breastmilk due to high levels of plasma protein binding.

The following applies to the ingredients: Metformin

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Available data have not reported adverse effects in breastfed infants, however, this data is limited.
-Due to this limited data, product manufacturers recommend a decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
-Published data suggest this drug is compatible with breastfeeding; they recommend caution when nursing a newborn or premature infant, and those with renal impairment.

Drug levels are expected to be 0.5% (range 0.11% to 1%) of the mother's weight-adjusted dosage and milk/plasma ratio range between 0.13 and 1. Since milk levels are expected to be relatively constant, timing of breastfeeding with drug administration is expected to be of little benefit. One large prospective study found no adverse effects in breastfed infants. Low detectable serum levels were found in some breastfed infants.